On October 10, 2006 the Ministry of Health, Labor and Welfare of Japan, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), and the US FDA held a conference on drug review and safety to assess current pharmaceutical regulations and trends in both countries. One of the main focuses in this meeting was to address “drug lag” in Japan. Often, New Drug Approval takes two years in Japan as opposed to the one-year approval time in the US. To alleviate this lag, the PMDA has established an office focused on the promotion of drug review. This “review promotion office” will allocate increased resources and personnel specifically for new drug review; such a facility did not previously exist.
Another aspect contributing to this drug lag is clinical trial protocols for foreign medical products in Japan. There are no base guidelines nor specific laws on what types of foreign clinical trial data are acceptable for each product. In many cases, the PMDA must work on a case-by-case basis for each medical product with independent Japanese experts to determine if clinical trials must be done in Japan, how many participants are required, how the study should be conducted, what data is required to fulfill clinical trial requirements in Japan, and other specific logistical issues. This need to work case-by-case is one of the main contributors to drug lag. Therefore, the PMDA is now currently working with experts in specific fields such as anticarcinogens and allergy medicines to establish clinical trial guidelines for different product types.
Other planned changes include expanding the number of reviewers for the biopharmaceuticals division and hiring more specialists in biologics. The PMDA has also suggested the development of a two-tier system. In this system, products would be divided into priority and non-priority groups, and each group would be reviewed by different teams.